ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000244101

Ethics application status

Approved

Date submitted

12/02/2019

Date registered

19/02/2019

Date last updated

22/10/2021

Date data sharing statement initially provided

19/02/2019

Date results information initially provided

22/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Quitlink: Peer worker facilitated Quitline support for smokers receiving mental health services

Scientific title

Quitlink: A randomised controlled trial of peer worker facilitated Quitline support for smokers receiving mental health services

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1209-3796

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tobacco smoking

Severe mental illness

Condition category

Condition code

Public Health

Other public health

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Mental Health

Depression

Mental Health

Other mental health disorders

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention (Quitlink)
Intervention participants will receive standard smoking care as in the control condition plus additional support. As in the control condition, the standard care is delivered by a peer worker (either verbally by the peer worker for face-to-face or telephone assessments; or via a video for online participants). and includes advice to quit, encouragement to use NRT, and a Quit Victoria pack of written materials to motivate a quit attempt (e.g. costs of smoking and benefits of quitting) and resources to support self-management (e.g. Quitline phone number, ‘4Ds’ strategy: Delay, Deep-breathe, Drink water, Do something else’ to manage cravings; using NRT products).
With consent, a letter will be sent by the research team to nominated health professionals (GP/psychiatrist) with information about their client’s trial participation and a link to Australia’s smoking cessation guidelines for health professionals, which includes a list of medications affected by smoking.
Additionally, the intervention group will receive:
• Referral to Quitline: immediately following the brief intervention, the peer worker will make a proactive referral to Quitline. For participants recruited online, the Quitline referral will be made automatically by RedCap.
• Manual guided Quitline counselling: Quitline will then call the participant to offer the Quitlink service. This service includes up to seven scheduled calls with additional calls allowed to deal with relapse crises within an eight-week period. Calls are scheduled approximately weekly or according to caller preference for pre-quit calls and post-quitting calls follow a relapse-sensitive schedule. It includes structured monitoring of mental health symptoms, nicotine withdrawal symptoms and medication side-effects; and a focus on psychoeducation including the relationship between smoking and mood; goal setting; identification of triggers to smoke; and facilitating problem solving and skills building, including the use of mood management strategies that also act to aid cessation (e.g., exercise, scheduling pleasant activities). A dedicated Quitline counsellor will manage the quitting process for each participant.
• As in the control condition, with consent, a letter will be sent to the person’s general practitioner and/or psychiatrist. Additionally for the intervention condition, peer reviewed articles that provide practical advice to assist doctors in helping people with mental illness to quit smoking will be included (Mendelsohn and Montebello, 2013; Mendelsohn et al., 2015). Additionally, participants will receive a Quit Victoria brochure for carers and a Quit Victoria stop smoking moods and experiences diary.
• Quitline engagement with mental health services: Quitline will provide written feedback to treatment providers at the end of the telephone counselling program. Providers will be encouraged to monitor and support cessation efforts whenever appropriate. In addition, Quitline will contact the mental health treatment provider, if concerns arise about mental health issues.
• NRT: Participants will initially be provided with a four week supply (enough for daily use) of patches plus their choice of oral-form NRT (gum, lozenge, inhalator, spray). These products include:
* Patch (Transdermal; 21mg)
* Gum (Oromucosal; 2 mg)
* Lozenge (Oromucosal; 2 mg)
*Inhalator (Oromucosal; 15mg per cartridge)
* Spray (Oromucosal; 1mg 150 sprays)
The research team will post NRT to participants with an information pack that includes printed instructions on how to use NRT correctly, for how long, potential side effects (and when to notify a health care provider), and safe storage and handling. Quitline counsellors will monitor and encourage correct use of NRT and address barriers to use. Intervention participants that decide to use the supplied NRT will receive a final 4-week supply of NRT as per the initial supply. Quitline counsellors will ask participant preferences for oral dose forms during the Week 2 call (for those participants that do not engage with Quitline, the peer worker will contact participants to determine participant preferences for NRT) in order for NRT to be delivered to the participant by Week 4. Participants who desire to shift to use of a prescription-based stop smoking medication (e.g., varenicline) will be supported to do so, but the study will not fund the purchase (which is low for those with health care cards as it is heavily government subsidized).
The Quitlink intervention is similar to the Quitline’s routine care for clients disclosing mental health issues. Components unique to this trial include the peer worker referring to Quitline, a dedicated counsellor for each participant and provision of NRT.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Control
Participants will receive standard smoking care. The standard care is delivered by a peer worker (either verbally by the peer worker for face-to-face or telephone assessments; or via a video for online participants) and includes advice to quit, encouragement to use NRT, and a Quit Victoria pack of written materials to motivate a quit attempt (e.g. costs of smoking and benefits of quitting) and resources to support self-management (e.g. Quitline phone number, ‘4Ds’ strategy: Delay, Deep-breathe, Drink water, Do something else’ to manage cravings; using NRT products). With consent, a letter will be sent by the research team to nominated health professionals (GP/psychiatrist) with information about their client’s trial participation and a link to Australia’s smoking cessation guidelines for health professionals, which includes a list of medications affected by smoking.

Control group

Active

Outcomes

Primary outcome [1]

Continued abstinence The primary outcome is defined as continued abstinence from smoking since the end of the treatment period, i.e., 6 months sustained abstinence, with no relapse (defined as 7+ days of continuous smoking, and no reported smoking in the last week), at 8-month follow-up. Sustained abstinence will be assessed via the following question: “When did you last smoke a cigarette, even a puff?”

Timepoint [1]

8 months post baseline (allowing participants up to 2 months to stop).

Secondary outcome [1]

7-day point prevalence abstinence, based on “Have you smoked at least part of a cigarette in the last seven days?”

Timepoint [1]

2, 5 and 8 months post baseline.

Secondary outcome [2]

Reported cigarettes smoked per day (for daily smokers) or cigarettes per week (for non-daily smokers).

Timepoint [2]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [3]

Expenditure on cigarettes measured by self-reported cigarette consumption (cigarettes per day/week x current market average price) x (no. of smoking days/weeks over the outcome time period assessed)

Timepoint [3]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [4]

Number of quit attempts of 24 hours or more, 1 week or more, and 1 month or more in the previous 3 months or since last assessed. Assessed by questionnaire item designed for this study 'since you joined the study - have you made a quit attempt?'

Timepoint [4]

2-, 5- and 8-months post baseline.

Secondary outcome [5]

Time to relapse. In those who do relapse will be assessed by questionnaire item designed for this study ' How long ago did you relapse back to smoking?'

Timepoint [5]

2-, 5- and 8-months post baseline.

Secondary outcome [6]

Number of subsequent quit attempts among those who relapsed. Assessed by questionnaire item designed for this study ' How long ago did you relapse back to smoking?'

Timepoint [6]

2-, 5- and 8-months post baseline.

Secondary outcome [7]

Hospitalizations and other intensive health service use. Assessed by questionnaire items designed for this study.

Timepoint [7]

2- and 8-months post baseline.

Secondary outcome [8]

Financial stress (questions adapted from Siahpush and Carlin, 2006).

Timepoint [8]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [9]

Productivity impacts (time off work or other duties). Assessed by questionnaire items designed for this study.

Timepoint [9]

2-, 5- and 8-months post baseline.

Secondary outcome [10]

Nicotine dependence measured by the Heaviness of Smoking Index (HSI). Nicotine dependence is assessed using this two item Index to create a total score (Heatherton et al., 1989; Kozlowski et al., 1994). It uses a six-point scale calculated from the number of cigarettes smoked per day (1-10, 11-20, 21-30, 31+) and the time to first cigarette after waking (less than/equal to 5, 6-30, 31-60, and 61+ minutes). The HSI has been found to have good reliability and reasonable predictive validity (Borland et al., 2010).

Timepoint [10]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [11]

Cravings are assessed by one item taken from the International Tobacco Control (ITC) Four Country Survey (Herd and Borland, 2009; Herd et al., 2009), “Currently, how often do you get strong cravings to smoke tobacco?” with the response options of: 1) Hourly or more often; 2) Several times per day; 3) At least once a day; and 4) Less than daily.

Timepoint [11]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [12]

Difficulty in coping with situations in which smoking is not allowed is also assessed, on a 4-point Likert Scale from ‘very’, ‘moderately’, ‘mildly’ to ‘not at all difficult’.

Timepoint [12]

2-, 5- and 8-months post baseline.

Secondary outcome [13]

Psychological distress is measured by the Kessler Psychological Distress Scale (Kessler-10; Kessler et al., 2003) a 10-item scale of non specific psychological distress with a total score. It has shown consistent psychometric properties across major sociodemographic subsamples (Kessler et al., 2002).

Timepoint [13]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [14]

Alcohol use is assessed by the Alcohol Use Disorders Identification Test – Brief (AUDIT-C; Bush et al., 1998) a three item screening tool used to identify hazardous alcohol use or active alcohol use disorders. It is scored on a scale of 0-12 to create a total score. For men, it has been shown to have a sensitivity of .90 and specificity of .45; for women the sensitivity is .80 and specificity is .87.

Timepoint [14]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [15]

Cannabis use is assessed by the Cannabis Use Disorders Identification Test – Revised (CUDIT-1 R; Adamson et al., 2010) is a briefer (8-item) and more refined version of the CUDIT (Adamson and Sellman, 2003), a simple modification of the AUDIT. Items cover the domains of consumption, cannabis problems, dependence and psychological features. The CUDIT-R was found to comprise a single factor, with high test-retest reliability (r=0.871), high internal consistency (a=0.914) and discriminant validity (area under the curve = 0.960). Only question 1, “How often do you use cannabis? (over the last 2 months)” is included in the present study (never, monthly or less, 2 to 4 times a month, 2 to 3 times a week, 4 or more times a week). In addition, participants who use cannabis are asked “Do you ever mix tobacco with your cannabis?” with response options of “Yes, always or nearly always”, “Yes, sometimes” or “No, never or very rarely.”

Timepoint [15]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [16]

Covariate or process measure at follow up
Motivation to quit: assessed by a single question adapted from Crittenden et al. (1994), “Are you trying to quit smoking altogether or are you planning to keep smoking at this level?”

Timepoint [16]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [17]

Covariate or process measure at follow up
Self-efficacy in quitting is measured by the following question adapted from Perkins et al. (2012): “How confident are you that you will not smoke at all tomorrow?” (not at all, somewhat, moderately, very, extremely). For those who quit at follow-up, “How confident are you that you will be able to stay quit long-term and become a permanent ex-smoker?” (not at all, somewhat, moderately, very, extremely).

Timepoint [17]

Baseline, 2-, 5- and 8-months post baseline.

Secondary outcome [18]

Covariate or process measure at follow up
Medications: Changes in use of prescribed psychotropic medication assessed by questionnaire item designed for this study.

Timepoint [18]

2-months post baseline.

Secondary outcome [19]

Covariate or process measure at follow up
Treatment received (use of NRT and Quitline – number and length of calls) assessed by questionnaire items designed for this study.

Timepoint [19]

2-, 5- and 8-months post baseline.

Secondary outcome [20]

Covariate or process measure at follow up
Quitline use - objective data on service use (number and length of calls) will be extracted from the Quitline database for all participants (as some control participants may have self-referred).

Timepoint [20]

8-months post baseline.

Secondary outcome [21]

Covariate or process measure at follow up
Therapeutic alliance with Quitline counsellor : the 3-item Working Alliance Inventory for Tobacco (Warlick et al., 2018), measuring goal, task and bond on a 5 item Likert Scale (seldom, sometimes, fairly often, very often, always) will be administered. The 3-item measure has been found to have acceptable-good internal consistency and construct validity.

Timepoint [21]

2-months post baseline.

Secondary outcome [22]

Covariate or process measure at follow up
Self-reported service use and satisfaction: participants’ use and assessment of level of support they have received for quitting from their mental health service, doctors and other health professionals assessed by questionnaire items designed for this study.

Timepoint [22]

2-months post baseline.

Secondary outcome [23]

Covariate or process measure at follow up
Linked data on service and prescription medication use from the Australian Government subsidised Medicare and Pharmaceutical Benefits Schemes.

Timepoint [23]

8-months post baseline.

Eligibility

Key inclusion criteria

Participant inclusion criteria are: aged at least 18 years; residing in Victoria; smoking at least 10 cigarettes per day; and accessing treatment or support from participating mental health
agencies.
In addition to the site based recruitment above, community based online recruitment was added for people meeting the age, location and smoking requirements above but rather than accessing treatment or support from participating site based services, potential participants could be accessing any treatment, support or care service for a mental health or drug and alcohol condition.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria are: current engagement in Victorian Quitline’s callback service; no ready access to a telephone; inability to complete informed consent and/or the screening survey; acute suicidality; myocardial infarction or unstable arrhythmia or angina within the previous two weeks (NRT contraindications); and pregnancy (as smokers who are pregnant already receive a different extended Quitline callback service).

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The computer program used to complete the baseline will randomize to condition using 1:1 randomisation. Participants will be randomly allocated to either no further intervention, or to be contacted by Quitline who will offer a targeted callback counselling intervention with NRT provided, over an eight-week period. Randomisation will be independently managed by the trial epidemiologist and uploaded to a web-based data capture tool (Research Electronic Data Capture; REDCap) that will also have case report forms (eCRF) created for the project using REDCap.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Due to the nature of the intervention under investigation (i.e., linking smokers to existing smoking cessation care options readily available in the community, quitline and NRT) there is a high risk of contamination among residential services where participants may compare treatment received. Therefore, we will use a partial clustering design where cluster randomisation will be used in situations where risk of contamination is particularly high (e.g. in residential services) stratified by short- or long-term residence, with 1:1 allocation. Individual randomisation will be used in services where contamination risk is lower, via permutated block sizes of 4 and 6 to avoid incomplete blocks, stratified for site.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size determination
We anticipate that for the primary outcome of prolonged abstinence at 8 months, success will occur in 1% of the control arm vs 8% in the intervention arm. To detect this effect with 80% power at p=0.05, we need 134 per arm. We expect ~30% attrition, inflating the sample size to 191/arm or 382 overall. We will recruit 382 smokers over 36 months (12/month with additional time for periods of slowed recruitment; with treatment finishing after 38 months) and follow them up at 2-, 5- and 8-months post-baseline, completing the study over a 4.5-year period.

Statistical analyses
Independent and blinded statisticians from the CReDITSS Unit at the Hunter Medical Research Institute, Australia, will conduct analyses of the primary and secondary outcomes. Analyses will be carried out using a cluster randomised trial framework where the individuals (n=150) are treated as clusters that contribute only 1 person, the short-term residential programs are clusters that contribute an average of 15 people each (10 programs x 15 people/program = 150 total) and the long-term programs are clusters that contribute 10 people each (6 programs x 10 people/program = 60). We will use a generalised linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle the clustering and the repeated measures at baseline, 2-, 5- and 8- months; individuals will be modelled as random effects, cluster as a random effect, and group assignment as a fixed effect. Mixed models allow for missing data for the primary intention to treat analysis, but a sensitivity analysis using a worst case scenario (baseline value for continuous outcomes or relapse for dichotomous outcomes in case of missing value) will also be carried out. Intervention participants who do not complete the intervention, and participants who miss an assessment follow-up time point, will be kept in the study and contacted for later assessments (unless they choose to withdraw from the follow-up assessments).

Exploratory analyses
We plan to examine whether the amount of intervention (Quitline counselling, NRT) received by participants is related to outcomes. We will also explore different imputation strategies for missing data related to outcomes.

Economic evaluation
A cost-effectiveness analysis of Quitlink will be conducted alongside the trial described here, using data 8 months post randomisation. A modelled analysis will estimate future costs and benenfits of smoking cessation beyond the trial period, over the life course. In brief, incremental cost-effectiveness ratios (ICER) will be calculated for the cost ($AUD) per successful quit and quality adjusted life year (QALY) gained (ie.cost-utility) as a result of Quitlink when compared with usual care. Healthcare system and limited societal perspectives will be taken.

Qualitative evaluation
A nested qualitative study will be conducted. All interviews (participants and workers) will
be audio recorded, transcribed and a general inductive approach will be taken to the analysis (Thomas, 2006).

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

25/02/2019

Actual

20/03/2019

Date of last participant enrolment

Anticipated

31/03/2021

Actual

29/04/2021

Date of last data collection

Anticipated

31/01/2022

Actual

Sample size

Target

382

Accrual to date

Final

111

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

16 Marcus Clarke Street
Canberra City ACT 2600

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/04/2018

Approval date [1]

18/07/2018

Ethics approval number [1]

HREC 097/18

Ethics committee name [2]

University of Newcastle HREC

Ethics committee address [2]

University Drive
Callaghan NSW
2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/04/2018

Approval date [2]

28/08/2018

Ethics approval number [2]

Ethics committee name [3]

Cancer Council Victoria HREC

Ethics committee address [3]

615 St Kilda Rd
Melbourne Victoria
3004 VIC

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

23/08/2018

Approval date [3]

21/12/2018

Ethics approval number [3]

Summary

Brief summary

Smoking is the leading cause of preventable death in people with severe mental illness (SMI). Although smokers with SMI want to quit, tailored interventions are rarely delivered in practice. Quitlines are well placed but underutilised by this group. “Quitlink” will utilise peer workers within mental health services to engage smokers with SMI in a tailored Quitline intervention.
382 participants will be recruited across participating mental health services in Victoria. In addition to recruitment across participating mental health services in Victoria, recruitment will occur via community recruitment online across broader Victoria. All participants will receive a brief smoking cessation intervention. Participants will be randomly allocated to either no further intervention, or to the Quitlink intervention (proactively contacted by Quitline and offered a targeted smoking cessation counselling intervention with nicotine replacement therapy (NRT) provided over an 8 week period). All participants will be followed up at 2 months, 5 months and 8 months. We will also qualitatively examine facilitators and barriers to cessation in order to improve future interventions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Amanda Baker

Address

University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 412267164

Fax

[email protected]

Contact person for public queries

Name

Prof Amanda Baker

Address

University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 412267164

Fax

[email protected]

Contact person for scientific queries

Name

Dr Kristen McCarter

Address

University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 2 4033 5721

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1360	Study protocol				Submitted to Journal - Frontiers in Psychiatry 30 ... [More Details]

Results publications and other study-related documents

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Protocol for an Economic Evaluation of the Quitlink Randomized Controlled Trial for Accessible Smoking Cessation Support for People With Severe Mental Illness.	2019	https://dx.doi.org/10.3389/fpsyt.2019.00618
Embase	"QuitLink"-a randomized controlled trial of peer worker facilitated quitline support for smokers receiving mental health services: Study protocol.	2019	https://dx.doi.org/10.3389/fpsyt.2019.00124
Embase	Adapting Peer Researcher Facilitated Strategies to Recruit People Receiving Mental Health Services to a Tobacco Treatment Trial.	2022	https://dx.doi.org/10.3389/fpsyt.2022.869169
Embase	The value of compassionate support to address smoking: A qualitative study with people who experience severe mental illness.	2022	https://dx.doi.org/10.3389/fpsyt.2022.868032

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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